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Approved Drug Products containing Amphotericin B listed in the FDA Orange Book. Original Data : FDA Website

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01 1ABBOTT

02 1ABRAXIS PHARM

03 2ALKOPHARMA USA

04 4APOTHECON

05 1ASTELLAS

06 1BRISTOL MYERS SQUIBB

07 1EUGIA PHARMA

08 1LEADIANT BIOSCI INC

09 1SPIL

10 1TEVA PARENTERAL

11 1XGEN PHARMS

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : AMPHOTERICIN B

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/VIAL

Approval Date : 1987-04-13

Application Number : 62728

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : AMPHOTEC

Dosage Form : INJECTABLE, LIPID COMPLEX;INJECTION

Dosage Strength : 50MG/VIAL

Approval Date : 1996-11-22

Application Number : 50729

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : AMPHOTEC

Dosage Form : INJECTABLE, LIPID COMPLEX;INJECTION

Dosage Strength : 100MG/VIAL

Approval Date : 1996-11-22

Application Number : 50729

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : AMBISOME

Dosage Form : INJECTABLE, LIPOSOMAL;INJECTION

Dosage Strength : 50MG/VIAL

Approval Date : 1997-08-11

Application Number : 50740

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : FUNGIZONE

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 3%

Approval Date : 1982-01-01

Application Number : 50313

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : FUNGIZONE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 3%

Approval Date : 1982-01-01

Application Number : 50314

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : FUNGIZONE

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 100MG/ML

Approval Date : 1982-01-01

Application Number : 50341

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : FUNGIZONE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/VIAL

Approval Date : 1982-01-01

Application Number : 60517

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : FUNGIZONE

Dosage Form : LOTION;TOPICAL

Dosage Strength : 3%

Approval Date : 1982-01-01

Application Number : 60570

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

AMPHOTERICIN B

Brand Name : ABELCET

Dosage Form : INJECTABLE, LIPID COMPLEX;INJECTION

Dosage Strength : 5MG/ML

Approval Date : 1995-11-20

Application Number : 50724

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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